SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT— 510(k) K982608

Name: FDA 510(k) clearance K982608
Creator: U.S. Food and Drug Administration
Published: 1998-08-19

Substantially Equivalent

Sangui Biotech, Inc.

FDA 510(k) clearance K982608 for SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT, Substantially Equivalent on 1998-08-19. Applicant: Sangui Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Sangui Biotech, Inc.
Product code: Code CKG
Device class: Class 2
Regulation: 21 CFR 862.1025
Advisory panel: Clinical Chemistry
Date received: 1998-07-27
Decision date: 1998-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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